(198 days)
The Swabbable Cap provides temporary aseptic closure of the male luer connector of the IV tubing while disconnected from the patient, replacing the need for disposable caps to maintain aseptic procedure. The device is designed to be permanently attached to an IV administration set and used over the life of the administration set.
Provides temporary aseptic closure of the male luer connector of the IV tubing while disconnected from the patient, replacing the need for disposable caps to maintain aseptic procedure.
This looks like a 510(k) premarket notification for a medical device called the "PadLock™ Swabbable Cap." This document does not describe a study involving AI or machine learning. It describes a traditional medical device and its predicate device. Therefore, many of the requested fields related to AI study design and performance evaluation are not applicable.
Here's an analysis based on the provided text, focusing on what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain explicit acceptance criteria or a detailed report of device performance from a study. It describes the device, its intended use, classification, and predicate device. The 510(k) process primarily demonstrates substantial equivalence to a predicate device, which often involves comparison of technological characteristics and performance specifications rather than a new study with explicit acceptance criteria provided in this summary.
2. Sample size used for the test set and the data provenance
Not applicable, as no clinical study or test set for an algorithm is described in this document. This is a traditional medical device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
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SECTION 5: 510(k) SUMMARY
| Submitted by: | Baxa Corporation | AUG - 3 2007 | |
|---|---|---|---|
| Contact Person: | Kimberly Zizik | (303) 617-2242(303) 690-4204 | |
| Phone:Fax: | |||
| Date Prepared: | |||
| Manufacturing Facility: | Baxa Corporation14445 Grasslands DriveEnglewood, CO 80112Establishment registration number 1419106 | ||
| Submitted Device: | PadLock™ Swabbable CapCommon Name: Set, Intravascular Administration (ODI) | ||
| Product Code: | ODI | ||
| Device Classification: | Class IIClassification: 21 CFR § 880.5440 Intravascularadministration set(a) Identification . An intravascular administration set is adevice used to administer fluids from a container to apatient's vascular system through a needle or catheterinserted into a vein. The device may include the needle orcatheter, tubing, a flow regulator, a drip chamber, an infusionline filter, an I.V. set stopcock, fluid delivery tubing,connectors between parts of the set, a side tube with a capto serve as an injection site, and a hollow spike to penetrateand connect the tubing to an I.V. bag or other infusion fluidcontainer.(b) Classification . Class II (performance standards) | ||
| Predicate Device: | Trade Name: Dual Luer Lock CapCommon Name: Set, Intravascular AdministrationClassification Name: [880.5440] Intravascular AdministrationSet (Class II) (FPA)Manufacturer: Baxter Healthcare Corporation510(k) Number: K981318 | ||
| Product Description: | Provides temporary aseptic closure of the male luerconnector of the IV tubing while disconnected from thepatient, replacing the need for disposable caps to maintainaseptic procedure. | ||
| Intended Use: | The PadLock Swabbable Cap provides temporary asepticclosure of the male luer connector of the IV tubing whiledisconnected from the patient, replacing the need fordisposable caps to maintain aseptic procedure. The deviceis permanently attached to IV tube sets for general hospitaluse and is used repeatedly for the life of the administrationset. |
Image /page/0/Picture/3 description: The image shows the word "Baxa" in a bold, sans-serif font. The letters are evenly spaced and the word is centered. The font appears to be a digital font, with a slightly pixelated appearance.
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Fax
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 3 2007
Ms. Kimberly Zizik Regulatory Assurance Supervisor Baxa, Corporation 14445 Grasslands Drive Englewood, Colorado 80112
Re: K070163
Trade/Device Name: Swabbable Cap Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: ODI Dated: July 20, 2007 Received: July 23, 2007
Dear Ms. Zizik:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Zizik
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Clur
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K070163
Device Name: Swabbable Cap
Indications for use:
The Swabbable Cap provides temporary aseptic closure of the male luer connector of the IV tubing while disconnected from the patient, replacing the need for disposable caps to maintain aseptic procedure. The device is designed to be permanently attached to an IV administration set and used over the life of the administration set.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Division Control, Dental Devices
Page 1 of 1
K 974163 510(k) Number: __
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.